FDA Ramps Up Focus on Advertising of Restricted Devices to Consumers

By Jeffrey K. Shapiro –

FDA has enhanced authority over the sale, distribution and use of devices that the agency designates as “restricted.”  21 U.S.C. § 360j(e).  FDA almost always designates Class III devices as “restricted devices” in premarket application (“PMA”) approval orders.  21 U.S.C. § 360e(d)(1)(B)(ii).  Some Class III devices perform elective procedures that tend to be advertised to consumers by surgical centers and other user facilities.  As a practical matter, FDA has seldom issued warning letters to user facilities in connection with such advertising.

That may be changing.  In 2011 and 2012, FDA issued a spate of warning letters directed to advertising of the LapBand gastric banding system (“LapBand”) for weight loss (see, e.g., here).  The LapBand is manufactured by Allergan, but the letters were directed to surgical centers and other facilities advertising the procedure to consumers. 

In each case, FDA asserted that the device has been misbranded while in commerce because the advertisements failed to disclose information describing the risks associated with this surgery, patient eligibility requirements, and the need for ongoing modification of eating habits – all of which are in the approved LapBand labeling.  The asserted legal theory is that the failure to disclose risk information renders the advertisements misleading (21 U.S.C. § 321(n)), and also violates an affirmative statutory requirement to disclose such risk information (21 U.S.C. § 352(r)).

On December 18, 2012, FDA issued four warning letters to surgical centers offering laser-assisted in-situ keratomileusis (“LASIK”) with WaveLight and VISX lasers (see here, here, here, and here). Again, the gravamen of each warning letter is that the advertisements fail to disclose key risk information found in the approved labeling for this laser vision correction device.  The asserted legal theory is the same as with the LapBand letters.

Clearly, FDA wants to see more risk information in consumer advertising for surgical procedures.  The agency also has obviously gotten comfortable with the legal basis for issuing these warning letters.  Therefore, it would not be surprising to see more of them.  Devices used for cosmetic surgery could become another target, since they are also heavily advertised to consumers. 

Bottom line — manufacturers of restricted devices may wish to do more to educate user facilities and contractually require them to comply with these requirements.  This step will help ensure that the manufacturer itself does not receive a warning letter.  It also may be helpful in avoiding the potential to damage the brand image that multiple warning letters may bring, even if directed at user facilities rather than the manufacturer directly.